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Calcineurin Inhibitor

LCP-Tacro (tacrolimus) for Kidney Failure

Phase 2
Waitlist Available
Research Sponsored by Veloxis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.

Eligible Conditions
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).
Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).
Evaluation of Steady State Tacrolimus Trough Levels (C24).
Secondary study objectives
Safety Evaluation
Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21.
Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7.
+4 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Active Control
Group I: LCP-Tacro (tacrolimus)Active Control2 Interventions
Experimental: LCP Tacro; investigational product LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.

Find a Location

Who is running the clinical trial?

Veloxis PharmaceuticalsLead Sponsor
41 Previous Clinical Trials
3,010 Total Patients Enrolled
1 Trials studying Kidney Failure
63 Patients Enrolled for Kidney Failure
CTI Clinical Trial and Consulting ServicesOTHER
35 Previous Clinical Trials
3,730 Total Patients Enrolled
1 Trials studying Kidney Failure
63 Patients Enrolled for Kidney Failure
Alan Glicklich, MDStudy DirectorVeloxis Pharmaceuticals
1 Previous Clinical Trials
44 Total Patients Enrolled
~3 spots leftby Nov 2025
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